For information, the company have announced that the phase III clinical trial did not meet its primary endpoint of prolonging event-free survival compared to chemotherapy and radiotherapy, and they will no longer be pursuing a Marketing Authorisation Application in this indication at this time. Therefore, NICE has decided to suspend this appraisal from its current work programme. As this appraisal has been referred NICE will continue to monitor any development and will update interested parties as and when the situation changes wording regarding the status of this appraisal.
| Status | Suspended |
| Technology type | Medicine |
| Decision | Selected |
| Reason for decision | Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources |
| Process | STA Standard |
| ID number | 6199 |
Email enquiries
- If you have any queries please email scheduling@nice.org.uk
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 05 July 2024 | Suspended. For information, the company have announced that the phase III clinical trial did not meet its primary endpoint of prolonging event-free survival compared to chemotherapy and radiotherapy, and they will no longer be pursuing a Marketing Authorisation Application in this indication at this time. Therefore, NICE has decided to suspend this appraisal from its current work programme. As this appraisal has been referred NICE will continue to monitor any development and will update interested parties as and when the situation changes wording regarding the status of this appraisal. |
| 03 June 2024 | Please note that following on from a request received from the company, the timelines for this appraisal have been revised and the appraisal is now anticipated to begin in mid-February 2025. These timings are based on a request from the company to reschedule the initial date set by NICE, in order to facilitate a suitably comprehensive and robust submission. |
| 25 October 2022 | Awaiting development. Status change linked to Topic Selection Decision being set to Selected |
For further information on our processes and methods, please see our CHTE processes and methods manual